Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- Oslo University Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Rate of patients with R0 resection
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of this study is to investigate feasibility of computer navigation-assisted surgery in particularly difficult cases of locally advanced (LARC) and recurrent (LRRC) rectal cancer where the standard surgical strategy is expected to result in incomplete tumour removal. The investigators hypothesize that computer navigation-assisted surgery can facilitate improved anatomic orientation in the pelvis enabling tumour removal with free margins in these cases.
Detailed Description
Curative treatment of rectal cancer requires surgical removal of the tumour. The key challenge in this surgery is to remove the tumour with free margins - R0 resection. Failure to achieve R0 resection often leads to recurrence, which is associated with risk of long-term suffering, poor quality of life and death for the patients. Achieving R0 resection is most difficult in advanced rectal cancer cases, where the tumour is threatening - and sometimes even growing into - neighbouring organs. Computer navigation-assisted surgery has typically been implemented where extreme surgical precision is necessary or in surgical fields with high anatomic complexity. In such settings, it contributes to preservation of vital anatomic structures close to the tumour, and ensures completeness of resection in cases of malignant disease. With this in mind, feasibility of navigation in surgically challenging rectal cancer cases will be investigated in this study. If found feasible, navigation could improve surgical management for patients who otherwise would not have the possibility of cure.
Investigators
Kjersti Flatmark
Professor
Oslo University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with LARC or LRRC (either biopsy verified, or demonstrated on MRI and confirmed by the MDT decision)
- •The MDT must deem standard surgical strategy at high risk of resulting in R1/R2 resection and computer-assisted navigation likely to improve the chances of obtaining R0 resection.
- •Written informed consent
Exclusion Criteria
- •Non-adenocarcinoma malignancies.
- •Unresectable distant metastatic disease or unresectable synchronous other malignancy
- •Patients deemed unfit to participation according to the MDT.
Outcomes
Primary Outcomes
Rate of patients with R0 resection
Time Frame: 2 years
Resection status will be determined by histopathological examination of specimen
Secondary Outcomes
- Assessment of whether pre-procedural plan was executed during surgery by comparing pre- and post-operative magnetic resonance imaging (MRI).(2 years)
- Assessment of whether pre-procedural plan was executed by comparing volume of intended resection with volume of resected specimen.(2 years)
- Assessment of surgeons' opinion on benefit of computer navigation through qualitative interviews.(2 years)
- Progression-free survivial (PFS)(5 years)
- Occurrence of 30 day morbidity and mortality assessed with the Accordion severity grading system of surgical complications(30 days after surgery)
- Assessment of patients quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(3 years)
- Overall survival (OS)(5 years)
- Rate of local (re-)recurrence after surgery(5 years)